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Stellate Ganglion Block for Hot Flushes in Men Treated With ADT

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Stellate ganglion block
Sham procedure
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Stellate ganglion block, hot flushes, androgen deprivation therapy, prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male
  • Age: >18 years
  • Mean daily flush frequency of 10 or more and a hot flush score of 15 or more
  • Treatment with ADT because of prostate cancer
  • Absence of any other cause of flushing

Exclusion Criteria:

  • Use of medication that affects flushing: oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlafaxine, gabapentin, luteinizing hormone-releasing hormone receptor antagonist
  • Still receiving chemotherapy of radiotherapy
  • Psychiatric disease
  • Any unstable concurrent disease
  • Allergic reactions against bupivacaine or contrast media.

Sites / Locations

  • Rijnstate Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham procedure

Stellate ganglion block

Arm Description

injection of NACL 0,9% in the stellate ganglion

injection of Bupivacaine 0,5% in the stellate ganglion

Outcomes

Primary Outcome Measures

Hot flush score

Secondary Outcome Measures

Full Information

First Posted
November 11, 2014
Last Updated
March 9, 2021
Sponsor
Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02295163
Brief Title
Stellate Ganglion Block for Hot Flushes in Men Treated With ADT
Official Title
Short-term Efficacy of Stellate Ganglion Block in Men to Reduce Hot Flushes Related to Androgen Deprivation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
no participants
Study Start Date
July 2014 (Actual)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
January 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rijnstate Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Androgen deprivation therapy (ADT) is widely used as standard therapy in the treatment of locally advanced and metastatic prostate cancer. Hot flushes and night sweats are one of the main side-effects of ADT. There are no successful and well-tolerable treatment options available. A possible treatment for hot flushes is stellate-ganglion block (SGB), used as a means of interrupting parts of the sympathetic nervous system involved in temperature regulation. Objective of this study: To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure
Detailed Description
Androgen deprivation therapy (ADT) is widely used as standard therapy in the treatment of locally advanced and metastatic prostate cancer. Hot flushes and night sweats are one of the main side-effects of ADT. There are no successful and well-tolerable treatment options available. A possible treatment for hot flushes is stellate-ganglion block (SGB), used as a means of interrupting parts of the sympathetic nervous system involved in temperature regulation. Objective of this study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Stellate ganglion block, hot flushes, androgen deprivation therapy, prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham procedure
Arm Type
Sham Comparator
Arm Description
injection of NACL 0,9% in the stellate ganglion
Arm Title
Stellate ganglion block
Arm Type
Experimental
Arm Description
injection of Bupivacaine 0,5% in the stellate ganglion
Intervention Type
Procedure
Intervention Name(s)
Stellate ganglion block
Intervention Description
7 ml of 0.5% bupivacaine will subsequently be injected next to the stellate ganglion to produce a sympathetic block.
Intervention Type
Procedure
Intervention Name(s)
Sham procedure
Intervention Description
7 ml of 0.9 % sodium chloride will subsequently be injected next to the stellate ganglion
Primary Outcome Measure Information:
Title
Hot flush score
Time Frame
4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male Age: >18 years Mean daily flush frequency of 10 or more and a hot flush score of 15 or more Treatment with ADT because of prostate cancer Absence of any other cause of flushing Exclusion Criteria: Use of medication that affects flushing: oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlafaxine, gabapentin, luteinizing hormone-releasing hormone receptor antagonist Still receiving chemotherapy of radiotherapy Psychiatric disease Any unstable concurrent disease Allergic reactions against bupivacaine or contrast media.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jw. kallewaard, MD
Organizational Affiliation
Rijnstate Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6815 AD
Country
Netherlands

12. IPD Sharing Statement

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Stellate Ganglion Block for Hot Flushes in Men Treated With ADT

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